April 24, 2024Medical DevicesFDA
Philips North America Llc recalls GYROSCAN T5, Magnetic Resonance System.
Hazard: Patient support table floor plate may be incorrectly installed.
April 24, 2024Medical DevicesFDA
Philips North America Llc recalls GYROSCAN T10-NT, Magnetic Resonance System.
Hazard: Patient support table floor plate may be incorrectly installed.
April 24, 2024Medical DevicesFDA
Philips North America Llc recalls GYROSCAN ACS-NT, Magnetic Resonance System.
Hazard: Patient support table floor plate may be incorrectly installed.
April 24, 2024Medical DevicesFDA
Philips North America Llc recalls Evolution Upgrade 3.0T, Magnetic Resonance System.
Hazard: Patient support table floor plate may be incorrectly installed.
April 24, 2024Medical DevicesFDA
Philips North America Llc recalls Enterprise 1.5T, Magnetic Resonance System.
Hazard: Patient support table floor plate may be incorrectly installed.
April 24, 2024Medical DevicesFDA
Philips North America Llc recalls Achieva XR, Magnetic Resonance System.
Hazard: Patient support table floor plate may be incorrectly installed.
April 24, 2024Medical DevicesFDA
Philips North America Llc recalls Achieva 3.0TX for PET, Magnetic Resonance System.
Hazard: Patient support table floor plate may be incorrectly installed.
April 24, 2024Medical DevicesFDA
Philips North America Llc recalls Achieva 3.0T for PET, Magnetic Resonance System.
Hazard: Patient support table floor plate may be incorrectly installed.
April 24, 2024Medical DevicesFDA
Philips North America Llc recalls Achieva 3.0T, Magnetic Resonance System.
Hazard: Patient support table floor plate may be incorrectly installed.
April 24, 2024Medical DevicesFDA
Philips North America Llc recalls Achieva 1.5T Initial, Magnetic Resonance System.
Hazard: Patient support table floor plate may be incorrectly installed.
April 24, 2024Medical DevicesFDA
Philips North America Llc recalls Achieva 1.5T Conversion, Magnetic Resonance System.
Hazard: Patient support table floor plate may be incorrectly installed.
April 24, 2024Medical DevicesFDA
Philips North America Llc recalls Achieva 1.5T, Magnetic Resonance System.
Hazard: Patient support table floor plate may be incorrectly installed.
April 24, 2024Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodiu
Hazard: Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. Results in a positive bias ranging from 2-16% -impacts calibrator, quality control (QC), and patient results.
April 24, 2024Medical DevicesFDA
Artivion, Inc recalls CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Hazard: The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
April 24, 2024Medical DevicesFDA
Unomedical A/S recalls Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Hazard: Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World (ROW) countries. The difference between the US IFU and the ROW IFU is the addition of an intended use section in the ROW IFU.
April 24, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
Hazard: Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
April 24, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 301
Hazard: Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
April 24, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-5
Hazard: Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
April 24, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0
Hazard: Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
April 24, 2024Medical DevicesFDA
Masimo Corporation recalls Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,
Hazard: Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
April 24, 2024Medical DevicesFDA
Masimo Corporation recalls Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
Hazard: Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
April 24, 2024Medical DevicesFDA
Masimo Corporation recalls Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
Hazard: Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
April 24, 2024Medical DevicesFDA
Masimo Corporation recalls Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
Hazard: Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
April 24, 2024Medical DevicesFDA
SonarMed Inc recalls AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
Hazard: Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
April 24, 2024Medical DevicesFDA
SURGICAL SPECIALTIES recalls POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
Hazard: Complaints have been received with allegations of Incorrect Needle Curvature.
April 24, 2024Medical DevicesFDA
Ethicon, Inc. recalls STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12I
Hazard: Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
April 24, 2024Medical DevicesFDA
Cook Incorporated recalls Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for va
Hazard: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
April 24, 2024Medical DevicesFDA
Cook Incorporated recalls Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneou
Hazard: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
April 24, 2024Medical DevicesFDA
Cook Incorporated recalls Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for v
Hazard: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
April 24, 2024Medical DevicesFDA
Cook Incorporated recalls Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to
Hazard: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility